Insulin Sensitivity/ResistanceHITNCT02745613
Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity
A study testing 8 weeks of combined exercise intervention in people with Insulin Sensitivity/Resistance, run by University of Texas, El Paso at 1 site in United States.
Trial summary
This study investigates whether: (i) a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity. (ii) being prediabetic affects exercise induced improvements in glycemic control. (iii) sex differences affect exercise induced improvements in glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity/Resistance
- What is being tested?
- 8 weeks of combined exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary/moderately active lifestyle
- Less than 150 minutes/wk. of structured exercise
- Physical activity level ≤ 1.4
Who cannot join
- Evidence of significant cardiovascular disease
- Screening blood pressure >140/90
- Pregnancy or breastfeeding
- Use of drugs affecting energy metabolism or body weight
- Excess alcohol, drug abuse, and smoking
- Eating disorder or eating attitudes interfering with study
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- Excessively or active individuals
- Unwillingness to abide by randomization
- Injury that prevents the performance of exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at El Paso
El Paso, Texas, 79968
About this study
Official title: Does a Family History of Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity?
This study investigates whether: (i) a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity. (ii) being prediabetic affects exercise induced improvements in glycemic control. (iii) sex differences affect exercise induced improvements in glycemic control.
Read the detailed description
A family history of T2D (FH+) is a risk factor for developing insulin resistance (which precedes T2D) and T2D (Ryder et al., 2003). Exercise training on the other hand has been shown to improve insulin sensitivity and is highly effective to prevent/manage T2D. However it is not known if early signs of insulin resistance appear before being clinically diagnosed and if the benefits of exercise which prevent/cure T2D, are limited to the offspring of Hispanic T2D parents. Therefore, the proposed study will determine 1) if normoglycemic (normal blood glucose) offspring of T2D parents are insulin resistant, using the gold standard method to measure insulin sensitivity and metabolic flexibility (ability to switch between carbohydrate and fat oxidation) 2) if 8 weeks of exercise training improves insulin sensitivity and metabolic flexibility to the same extent in FH+ compared to normoglycemic offspring of parents without any history of T2D (FH-) and 3) if 8 weeks of exercise training will change the blood, lipid and molecular profiles relevant to insulin sensitivity to same extent in FH+ compared to offspring of parents without family history of T2D (FH-). This study will also determine how differently individuals with prediabetes response to exercise compared to those with normal glucose and further investigate sex differences in cardiometabolic response to exercise training.
- Conditions
- Insulin Sensitivity/Resistance
- Being tested
- 8 weeks of combined exercise intervention
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 weeks of combined exercise interventionOther
The subjects will undergo an 8 week combined exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Family history of T2D | Experimental | The participants will undergo 8 weeks of combined exercise Receives: Other: 8 weeks of combined exercise intervention |
| No Family history of T2D | Experimental | The participants will undergo 8 weeks of combined exercise Receives: Other: 8 weeks of combined exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity will be measured hyperinsulinemic -euglycemic clamp
Measured: 8-weeks
Glycemic control (long term)
Glycated hemoglobin (HbA1c) will be measured from whole blood with a bench top chemistry analyzer
Measured: 8-weeks
Glycemic control (postprandial)
Postprandial glycemic control will be measured by an oral glucose tolerance test (OGTT)
Measured: 8-weeks
Glycemic variability
Glycemic variability will be assessed with glucose monitoring
Measured: 8-weeks
Secondary outcomes (4)
Cellular mitochondria function
Cellular oxygen consumption of peripheral blood mononuclear cells (PBMC) will be measured with seahorse analyzer.
Measured: 8-weeks
Cytokines
Interleukin (IL)-6 will be measured with enzyme-linked immunosorbent assay
Measured: 8-weeks
Blood gene expression markers of glycemic control
Blood microRNAs of glycemic control will be measured with quantitative polymerase chain reaction.
Measured: 8-weeks
Peripheral blood mononuclear cell (PBMC) markers of glucose metabolism
Peripheral blood mononuclear cell (PBMC) markers of glucose metabolism will assessed with flow cytometry.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2026
- Study completionMay 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Sensitivity/ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudip Bajpeyi, University of Texas, El Paso
- Investigators
- Sudip Bajpeyi, PhD., Principal investigator, University of Texas, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745613
- Sponsor's protocol ID
- 755513-1
- Acronym
- HIT
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2016
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Family History of Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity?
- ClinicalTrials.gov ID
- NCT02745613
- Acronym / sponsor ID
- HIT / 755513-1
- Conditions
- Insulin Sensitivity/Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2026 (actual)
- Study completion
- May 2026 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether: (i) a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity. (ii) being prediabetic affects exercise induced improvements in glycemic control. (iii) sex differences affect exercise induced improvements in glycemic control.
Detailed description
A family history of T2D (FH+) is a risk factor for developing insulin resistance (which precedes T2D) and T2D (Ryder et al., 2003). Exercise training on the other hand has been shown to improve insulin sensitivity and is highly effective to prevent/manage T2D. However it is not known if early signs of insulin resistance appear before being clinically diagnosed and if the benefits of exercise which prevent/cure T2D, are limited to the offspring of Hispanic T2D parents. Therefore, the proposed study will determine 1) if normoglycemic (normal blood glucose) offspring of T2D parents are insulin resistant, using the gold standard method to measure insulin sensitivity and metabolic flexibility (ability to switch between carbohydrate and fat oxidation) 2) if 8 weeks of exercise training improves insulin sensitivity and metabolic flexibility to the same extent in FH+ compared to normoglycemic offspring of parents without any history of T2D (FH-) and 3) if 8 weeks of exercise training will change the blood, lipid and molecular profiles relevant to insulin sensitivity to same extent in FH+ compared to offspring of parents without family history of T2D (FH-). This study will also determine how differently individuals with prediabetes response to exercise compared to those with normal glucose and further investigate sex differences in cardiometabolic response to exercise training.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family history of T2D | Experimental | Other: 8 weeks of combined exercise interventionThe participants will undergo 8 weeks of combined exercise |
| No Family history of T2D | Experimental | Other: 8 weeks of combined exercise interventionThe participants will undergo 8 weeks of combined exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary/moderately active lifestyle
- Less than 150 minutes/wk. of structured exercise
- Physical activity level ≤ 1.4
Key exclusion criteria (9 listed)
- Evidence of significant cardiovascular disease
- Screening blood pressure >140/90
- Pregnancy or breastfeeding
- Use of drugs affecting energy metabolism or body weight
- Excess alcohol, drug abuse, and smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8 weeks of combined exercise interventionThe subjects will undergo an 8 week combined exercise intervention | Other | Family history of T2D, No Family history of T2D |
Primary outcome
Insulin sensitivity
Time frame: 8-weeks
Insulin sensitivity will be measured hyperinsulinemic -euglycemic clamp
Glycemic control (long term)
Time frame: 8-weeks
Glycated hemoglobin (HbA1c) will be measured from whole blood with a bench top chemistry analyzer
Glycemic control (postprandial)
Time frame: 8-weeks
Postprandial glycemic control will be measured by an oral glucose tolerance test (OGTT)
Glycemic variability
Time frame: 8-weeks
Glycemic variability will be assessed with glucose monitoring
4 secondary outcomes
Cellular mitochondria function
Time frame: 8-weeks
Cytokines
Time frame: 8-weeks
Blood gene expression markers of glycemic control
Time frame: 8-weeks
Peripheral blood mononuclear cell (PBMC) markers of glucose metabolism
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudip Bajpeyi, PhD. principal investigator
University of Texas, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 weeks of combined exercise intervention in people with Insulin Sensitivity/Resistance, run by University of Texas, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 8-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.